Guidewire manipulation device

ABSTRACT

One preferred embodiment includes a guidewire manipulation device for manipulating a guidewire during a procedure. Preferably, the guidewire manipulation device includes a powered motor that drives a tandem roller assembly. The guidewire is passed through a hole positioned lengthwise through the device where the roller assembly engages the guidewire&#39;s outer surface. The interface of the manipulation device includes a power button that directs the internal roller assembly to roll the guidewire in a desired rotational direction. Additional interface controls are also preferable to provide a different roll patterns, depending upon surgeon preference and guidewire placement efficiency.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/809,207, filed on Jul. 25, 2015, which is a continuation of U.S.patent application Ser. No. 14/704,879, filed on May 5, 2015, now U.S.Pat. No. 9,119,942, which is a continuation of U.S. patent applicationSer. No. 11/874,836, filed on Oct. 18, 2007, now U.S. Pat. No.9,050,438, which claims the benefit of priority to U.S. Provisional App.No. 60/853,731, filed on Oct. 21, 2006, all of which are incorporated intheir entirety by reference herein for all purposes. Priority is claimedpursuant to 35 U.S.C. § 120 and 35 U.S.C. § 119.

BACKGROUND OF THE INVENTION

The present invention generally relates to the maneuvering of aguidewire in surgical procedures where an ‘endovascular’ technique isemployed to access vasculature of a patient. Additional backgroundinformation can be found in U.S. Pat. No. 5,634,475, the contents ofwhich are hereby incorporated by reference.

A guidewire is typically a semi-rigid probe used as an initial accesspoint for performing an endovascular procedure. The guidewire istwisted, bent, and otherwise maneuvered through an access vessel inorder to position the guidewire tip at a location a surgeon would liketo treat.

Convention guidewire manipulation methods often involve applying“torque” to the guidewire to aid its passage through tortuous andclogged vessels. This maneuver is performed by quickly and stifflyspinning the wire in one's fingertips. This torque helps curve ormanipulate the guidewire through an obstruction or difficult passageway.This technique is also known as “helicoptering”, alluding to thespinning blades of a helicopter.

However, applying torque remains difficult since guidewires areextremely thin in diameter and typically have a low friction surface.Additionally, the gloves of a surgeon are often coated with blood orsaline solution, further increasing the slickness of the guidewire. Inthis respect, helicoptering and similar maneuvers can be time consumingand inefficient. This inefficiency not only frustrates surgeons but alsoincreases procedure times and therefore procedure costs.

Present guidewire designs attempt to address these problems by providinga torque handle consisting of a plastic tube that is about 0.5 inches indiameter and three inches long that slips over the proximal end of theguidewire and locks in place. The surgeon manipulates this torque device(Olcott Torque Device) to facilitate rotational motion of the guidewireand grip.

These current techniques and practices have several problems. First, thecurrent torque devices require a surgeon to concentrate on spinning theguidewire with the attached torque device. The spinning techniquegreatly depends on the ability of the user and can be difficult tolearn. Thus, these devices remain inefficient and often highly dependenton the operator skill. Since it is highly desirably to place a guidewirequickly and therefore finish a procedure quickly, a more consistentlycontrollable guidewire placement device that overcomes thesedisadvantages is desired.

OBJECTS AND SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide a strong, non-slipgrip on a guidewire.

It is another object of the invention to use a powered motor to spin aguidewire on a surgeon's command.

It is another object of the Invention to spin the guidewire using amotorized guidewire spinning mechanism to provide optimal torque andtechnique that would thus be operator (i.e. surgeon) independent. Forexample, helicoptering with the spinning mechanism by rapidly twistingthe guidewire about 180 degrees to the left and then rapidly spinningthe guidewire to the right. In another example, rapidly spinning theguidewire in one direction.

It is another object of the invention to use a motorized mechanism tohelicopter the guidewire in a number of different patterns dependant onthe surgeon's need. Such patterns include, but are limited to a fullclockwise rotation, a full counterclockwise rotation, continuousclockwise or counterclockwise rotations or any combination of the above.

It is another object of the Invention to provide a vibration mechanismto allow the guidewire to vibrate to help the guidewire travel past adistal obstruction.

It is another object of the invention to utilize a roller mechanism toattain efficient traction on a guidewire. These rollers may berubberized to provide traction in case the wire is slippery from liquidsor due to a slick coating provided by the manufacturer.

It is another object of the invention to, via a roller system, allow formanual control of guidewire spinning using a large cog-like manualcontrol which would “torque” the guidewire using the surgeon's fingermotion. Gears within the system may also be used to maximize thesurgeon's finger motion efficiency. This manual control can be inaddition to, or instead of, a motorized embodiment.

It is another object of the invention to use a lever-operated system toprovide guidewire torque in an alternate embodiment with or withoutelectric motor power. This system provides guidewire torque in a varietyof patterns which mimics current surgical technique performed by hand.

In one preferred embodiment, the present invention is directed to aguidewire manipulation device for providing a user with guidewiremanipulation techniques. Preferably, the guidewire manipulation deviceincludes a lightweight housing (e.g., plastic) in which a powered motordrives a tandem roller assembly. The guidewire is passed through a holepositioned lengthwise through the device where the roller assemblyengages the guidewire's outer surface.

The interface of the manipulation device includes a power button thatdirects the internal roller assembly to roll the guidewire in a desiredrotational direction. Additional interface controls are also preferableto provide a different roll patterns, depending upon surgeon preferenceand guidewire placement efficiency.

In an alternate embodiment the roller assembly may be driven by a thumbwheel. Preferably, the roller assembly is spring-loaded, allowing thesurgeon to roll the thumb control wheel in one direction and then havethe guidewire automatically roll back in the opposite direction.

The manipulation device may be reusable or disposable and may includecontours to provide an ergonomic grip for the user.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a view of a guidewire manipulation device being usedon a patient according to a preferred embodiment of the presentinvention;

FIG. 2A Illustrates a top view of the guidewire manipulation device ofFIG. 1;

FIG. 2B illustrates a side view of the guidewire manipulation device ofFIG. 1;

FIG. 3 illustrates a top open view of the guidewire manipulation deviceof FIG. 1:

FIG. 4 illustrates a bottom open view of the guidewire manipulationdevice of FIG. 1;

FIG. 5 illustrates a cross sectional view of the rollers of theguidewire manipulation device of FIG. 1;

FIG. 6 illustrates a side view of a guidewire manipulation deviceaccording to a preferred embodiment of the present invention;

FIG. 7 illustrates a side view of the guidewire manipulation device ofFIG. 6 with a depressed trigger according to a preferred embodiment ofthe present invention;

FIG. 8 illustrates a side view of a guidewire manipulation deviceaccording to a preferred embodiment of the present invention;

FIG. 9 illustrates a side view of the guidewire manipulation device ofFIG. 8;

FIG. 10 illustrates a perspective view of a guidewire manipulationdevice according to a preferred embodiment of the present invention;

FIG. 11 illustrates a side cross sectional view of the guidewiremanipulation device of FIG. 10;

FIG. 12 illustrates a side cross sectional view of the guidewiremanipulation device of FIG. 10;

FIG. 13 illustrates a perspective open view of the guidewiremanipulation device of FIG. 10;

FIG. 14 illustrates a perspective open view of the guidewiremanipulation device of FIG. 10;

FIG. 15 illustrates a perspective open view of the guidewiremanipulation device of FIG. 10;

FIG. 16 illustrates a side open view of a guidewire manipulation deviceaccording to a preferred embodiment of the present invention;

FIG. 17 illustrates a side open view of the guidewire manipulationdevice of FIG. 16;

FIG. 18 illustrates a side view of a guidewire manipulation deviceaccording to a preferred embodiment of the present invention;

FIG. 19 illustrates a side open view of a guidewire manipulation deviceaccording to a preferred embodiment of the present invention;

FIG. 20 illustrates a side open view of the guidewire manipulationdevice of FIG. 19;

FIG. 21 illustrates a side open view of a guidewire manipulation deviceaccording to a preferred embodiment of the present invention; and

FIG. 22 illustrates a side open view of the guidewire manipulationdevice of FIG. 21.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a preferred embodiment of a guidewire manipulationdevice 100 which is advanced over a guidewire 102. As seen in thisfigure, the guidewire 102 is introduced into the vessel of the patient(e.g., a femoral artery). The manipulation device 100 is slid over theguidewire 102 and selectively locked on to the guidewire 102. As theguidewire 102 is advance into the patient, the user operates themanipulation device 100 to rotate or vibrate the guidewire 102 asappropriate.

For example, as a distal end of the guidewire 102 reaches an angled orcurved region of the vessel, the user activates the manipulation device100 to rotate the guidewire 102 (e.g., in a counter clockwise directionindicated by arrow 103), thereby causing the distal end of the guidewire102 to more easily advance through the angled or curved region. Inanother example, the distal end of the guidewire 102 reaches anobstruction (e.g., an embolism) but is unable to easily pass. The userthen activates the guidewire manipulation device 102 to vibrate (e.g.,by rotating between a clockwise and counter clockwise directionquickly), thereby causing the distal end of the guidewire 12 to passthrough the obstruction. In another example, the device 100 may includea multiple, preprogrammed rotation patterns appropriate for differentvessel configurations (e.g., a 180 degree clockwise rotation followed by180 degree counter clockwise rotation, a 90 degree clockwise rotationfollowed by 90 degree counter clockwise rotation or a 30 degreeclockwise rotation followed by 180 degree counter clockwise rotation).The device may also include a microprocessor and memory connected to themotor and button 108 for storing and executing the preprogrammedrotation patterns.

FIGS. 2A and 2B Illustrate external views of the guidewire manipulationdevice 100. As seen in these figures, the guidewire 102 passes through apassage along the length of the device 100. Preferably, the manipulationdevice 100 includes a locking assembly in the form of a guidewire lockswitch 106 which allows the user to selectively lock the device 100 tothe guidewire 102. In this respect, the device 100 can move relative tothe guidewire 102 in an unlocked state, and can move the guidewire 102in a locked state.

The device 100 also preferably includes a power indicator light 104(e.g., an LED) which indicates if the device 100 is powered on and arotation button 108 which causes the guidewire 102 to rotate.Optionally, the device 100 may include a button, switch or similarmechanism to toggle the device 100 between rotating in a clockwisedirection or a counter clockwise direction. Alternately, the button 108may include multiple actuation techniques for determining clockwise orcounter clockwise rotation (e.g., sliding forward or backward, multiplebutton presses, etc.).

Preferably, an outer container or casing 110 is composed of alight-weight material such as plastic and has an ergonomic shape that atleast partially fits in the user's hand. In this respect, the user cancomfortably operate the device 100 during a procedure.

Referring to FIGS. 3 and 4, an interior view of the device 100 withinthe outer casing 110 is illustrated according to a preferred embodimentof the present invention. The guidewire 102 is engaged by the device 100with elongated rollers 120 (also seen in the cross sectional view ofFIG. 5). Preferably the device 100 includes at least three rollers,however, any number of rollers 120 are possible (e.g., 1-5 rollers).When the button 108 is pressed, the rollers 120 rotate, thereby rotatingthe guidewire 102. Preferably, the lock 106 raises or lowers one or moreof the rollers 120 in relation to the guidewire 102, so as to lock theguidewire 102 with the device 100 when the rollers 120 are pressedagainst the guidewire 102 and unlock the guidewire 102 from the device100 when the roller(s) 120 are moved away from the guidewire 102.

One or more of the rollers 120 are preferably driven by a motor 116which is powered by battery 114 (or alternately by A.C. power such as anoutlet). The motor 116 connects to the rollers 120 by a cam 119 made upof a first linkage 118 connected to the motor 116 and a second linkage112 connected to the roller 120. In this respect, activation of themotor 116 drives the cam 119 and ultimately rotation of the roller 120.

FIGS. 6 and 7 illustrate another preferred embodiment of a manualmanipulation device 130 according to the present invention. The device130 is generally similar to the previously described device 100, exceptthat the rollers 120 and therefore rotation of the guidewire 102 isdriven by a handle 126. For example, depressing the handle 126 rotatesthe guidewire 102 in a clockwise direction (arrow 122) and releasing thehandle 126 rotates the guidewire 102 in a counter clockwise direction(arrow 124). Additionally, switch 124 is included to change a type ofrotation caused by the handle 126. For example, the switch 124 maychange a gear ratio and therefore the amount of rotation cause bydepressing the handle. In another example, the switch 124 may changedirections of rotation caused by depressing the handle 126.

FIGS. 8 and 9 illustrate another preferred embodiment of a manualguidewire manipulation device 132 which is generally similar to thepreviously described devices 100 and 130. However, the device 132includes a selectively locking thumb roller 133 on a distal end of thedevice 132. The thumb roller 132 includes a locked mode, seen in FIG. 8,in which the roller 134 is engaged with the guidewire 102, therebyallowing the user to roll the roller 134 and thus the guidewire 102. Thethumb roller 132 also includes an unlocked mode, seen in FIG. 9, inwhich the roller 134 is pulled distally from the casing 136, exposingspace 138 and disengaging the roller 134 from the guidewire 102. Thus,in the unlocked mode, the device 132 can be moved along the length ofthe guidewire 102.

FIGS. 10-15 illustrate another preferred embodiment of a guidewiremanipulation device 140 according to a preferred embodiment of thepresent invention. The device 140 is generally similar to the previouslydescribed device 100. For example, the device 140 includes a hand-held(e.g., sized to be held within a users hand), ergonomic, outer case 142and a manipulation button 144. As best seen in FIGS. 11 and 12, thedevice 140 also includes a motor 152 powered by a battery 154 and aguidewire passage 158.

Preferably, the device 140 includes a locking assembly in the form of alocking hub 146 (similar to the device 132) which allows the user toselectively lock the guidewire 102 with the device 140. The locking hub146 allows free movement of the guidewire 102 when positioned near thecase 142 (FIG. 17) and locks the guidewire 102 when the hub is pulledaway from the case 142 (FIG. 12). The hub 146 includes an interiorcavity with a top surface angled downward towards the case 142. Withinthe interior cavity is a locking wedge 150 which is located within awindow 149 of a tube 148 that exposes the guidewire 102. In the unlockedposition of FIG. 11, the hub 146 restrains the wedge 150 but does notpress down on the wedge 150, thereby allowing the guidewire 102 to slideunderneath the wedge 102. In the locked position of FIG. 12, the angledinterior surface of the hub 146 forces the wedge downward against theguidewire 102, preventing the guidewire from movement relative to thedevice 140. A perspective view of the wedge 150 can also be seen in FIG.15.

As seen in FIGS. 11-15, the motor 152 includes a worm gear 155 thatengages a first gear section 1568 of shaft 156. A second gear section156A of shaft 156 engages gearing 158A on the outer surface of tube 148.In this respect, when the motor 152 is activated, it ultimately rotatesthe roller assembly, or tube 148. Thus, the hub 146 must be in aslid-out, locked position to cause the guidewire 102 to rotate.

As with all motorized embodiments described in this specification, thedevice 140 may also include a microprocessor and memory for storing andexecuting different rotation sequences (i.e., rotation directions androtation speeds).

FIGS. 16 and 17 illustrate a guidewire manipulation device 170 accordingto yet another preferred embodiment according to the present invention.The device 170 is generally similar to previously described embodiments,including an outer case 184 having an actuation button 176 that iscoupled to a battery 186 and a motor 178. The gear 180 of the motor 178is engaged with a gear 182 that is also engaged with a geared section181 on wedge tube 174.

A hub 174 includes an interior, angled passage that increases indiameter in a distal direction. The wedge tube 174 is partiallypositioned within the hub 174. In the unlocked position of FIG. 16, theangled passage of the hub 172 complements a distally expanding shape ofthe wedge tube 174, thereby preventing the wedge tube 172 from clampingor providing force on the guidewire 102 and thus allowing the guidewire102 to slide and rotate relative to the device 170. In the lookedposition of FIG. 17, the hub 172 is moved distally from the case 184,causing the smaller diameter of the interior passage of the hub 172 towedge or clamp on to the expanded distal end of the wedge tube 174.Thus, the wedge tube 174 (preferably composed of a compressible,semi-compressible or deformable material) closes around the guidewire102, maintaining the position of the guidewire 102 relative to thedevice 170 and further allowing rotation of the guidewire 102.

FIG. 18 illustrates another preferred embodiment of a device 190according to the present invention. The device 190 is generally similarto the previously described devices. However, the device 190 includes alocking assembly in the form of a guidewire lock activated by depressinga trigger 196. In this respect, the user can rotate hub 192, eitherclockwise or counter clockwise to respectively rotate the guidewire 102.

FIGS. 19 and 20 illustrate another preferred embodiment of a guidewiremanipulation device 190 according to the present invention. The device190 is generally similar to the previously described embodiments,including a motor 210 powered by a battery, a gear 214 coupled to anoutput gear 212 of the motor 210 and to a geared portion 200B of a wedgetube 200 and a case 194 to contain the components. The motor 210 iscontrolled by a rocker switch 192 that is connected to a first circuitboard 202 which sends the position of the rocker switch 192 to thesecond circuit board 206. The second circuit board 206 includes amicroprocessor and memory for executing a plurality of rotationprograms. These rotation programs direct the motor 210 to makepredetermined rotation movements such as in a single direction,exponentially increasing rotational speed, quick rotation to causevibration or a predetermined series of rotational movements. Thus, morecomplicated movements can be performed by the user.

The device 190 locks on to the guidewire 102 when the user releasestrigger 196 (see FIG. 19) and unlocks the guidewire 102 when the userdepresses trigger 196. The trigger 196 moves an outer tubing 198 whichis biased in a distal direction by a spring 204. The interior passage ofthe outer tubing 198 increases in diameter in a distal direction formingan inverted cone shape. An inner wedge tube 200 is positioned within thepassage of the outer tubing 198 and includes a wedge 200A that increasesin size in a distal direction of the device 190. The guidewire 102 islocated within a passage of the wedge tube 200.

When the trigger 196 is released, as in FIG. 19, the outer tubing 198 ismoved distally by the spring 204, causing the smaller diameter region ofthe inner passage of the outer tubing 198 to press against the wedge200A of wedge tube 200. The wedge 200 then compresses around theguidewire 102, locking the guidewire 102 in place relative to the device190. When the trigger 196 is depressed, a portion of the trigger 196pushes the outer tubing 198 in a proximal direction, against the bias ofthe spring 204. The angled portions of the inner passage of the outertubing 198 move away from the wedge 200 a, allowing the inner passage ofthe wedge tube 200 to release the guidewire 102. Thus, the user canselectively lock on to and rotate the guidewire 102 (with the rollerassembly, including wedge tube 200) by releasing the trigger 196 andpressing the actuation button 192.

FIGS. 21 and 22 illustrate another preferred embodiment of a guidewiremanipulation device 220 according to the present invention. The device220 is generally similar to the previously described embodiments,including a battery 234 powering a motor 236 which drives a wedge tube224 (via a gear 240 connected to geared region 224B and output gear 238)and an actuation button 228.

The device 220 further includes a locking mechanism assembly that locksthe lateral position of the guidewire 102. As seen in FIG. 21, when theuser releases the trigger 232, the device remains in a locked position,allowing the user to rotate the guidewire 102. As seen in FIG. 22, whenthe user depresses the trigger 232, the device remains in an unlockedposition, allowing the user to slide the device 220 along the guidewire102 and preventing guidewire rotation.

In the locked position, the trigger 232 maintains an outer tube 222 in aproximal position, proximally biased by a spring 226. The outer tubeincludes an inner passage that generally decreases in diameter in adistal direction. The Inner surface of the outer tube 222 pressesagainst a wedge portion 224A of a wedge tube 224, causing the wedge tube224 to press against and lock onto the guidewire 102.

In the unlocked position, the trigger 232 pushes the outer tube 222distally, against the bias of the spring 226. The surface of the innerpassage of the outer tube 222 moves away from the wedge 224A, releasingthe wedge tube 224 from the guidewire 102.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A guidewire manipulation device comprising: acasing sized to at least partially fit within a user's hand; a passageextending along a length of said casing and sized for passage of aguidewire therethrough; a rotation assembly fixed within said casing andpositioned to engage said guidewire positioned within said passage; amotor disposed within said casing and operatively coupled to said rollerassembly so as to drive rotation of said roller assembly; a power supplyconnected to said motor; and an interface in communication with saidmotor for selectively actuating movement of said motor.
 2. The guidewiremanipulation device of claim 1, further comprising a lock assembly forselectively engaging said guidewire with said roller assembly.
 3. Theguidewire manipulation device of claim 1, wherein said rotation assemblycomprises a plurality of rollers.
 4. The guidewire manipulation deviceof claim 1, wherein said rotation assembly comprises a tube composed ofa compressible material.
 5. The guidewire manipulation device of claim1, wherein said rotation assembly comprises a tube including a window.6. The guidewire manipulation device of claim 5, further comprising awedge sized to at least partially move through said window.
 7. Theguidewire manipulation device of claim 2, wherein said lock assemblyselectively moves at least one roller.
 8. The guidewire manipulationdevice of claim 2, wherein said lock assembly comprises a hub disposedon said casing so as to slide between a locked position and an unlockedposition.
 9. The guidewire manipulation device of claim 2, wherein saidlock assembly comprises a trigger configured to slide a tube positionedaround said passage.
 10. A guidewire manipulation device comprising: acasing sized to at least partially fit within a user's hand; a passageextending along a length of said casing and sized for passage of aguidewire therethrough; a rotation assembly fixed within said casing andpositioned to engage said guidewire positioned within said passage; and,a manually actuated rotation mechanism at least partially disposedwithin said casing for driving said rotation assembly based on handmovement of a user.
 11. The guidewire manipulation device of claim 10,wherein said manually actuated rotation mechanism comprises adepressible handle coupled to said rotation assembly.
 12. The guidewiremanipulation device of claim 10, wherein said manually actuated rotationmechanism comprises a rotatable hub.
 13. The guidewire manipulationdevice of claim 10, further comprising an interface disposed on saidcasing for modifying rotation of said guidewire by said rotationassembly.
 14. The guidewire manipulation device of claim 10, furthercomprising a lock assembly coupled to said rotation assembly so as toselectively engage said rotation assembly with said guidewire.
 15. Amethod of manipulating a guidewire comprising: introducing a guidewireinto a patient; sliding said manipulation device over said guidewire;engaging a rotation assembly with said guidewire; advancing saidguidewire into said patient; actuating said manipulation device torotate said guidewire in a first direction.
 16. The method of claim 15,wherein said sliding said manipulation device over said guidewirefurther comprises holding said manipulation device in a hand.
 17. Themethod of claim 15, wherein said engaging a rotation assembly with saidguidewire further comprises selectively wedging a first member againstsaid guidewire.
 18. The method of claim 15, wherein said actuating saidmanipulation device to rotate said guidewire in a first directionfurther comprises activating a motor to drive said rotation assembly.19. The method of claim 15, further comprising executing a program fordetermining a preprogrammed rotation of said rotation assembly.
 20. Themethod of claim 15, wherein said actuating said manipulation device torotate said guidewire in a first direction further comprises manuallydriving said rotation assembly with a hand of said user.